N/A
N=623
Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04347291 ↗Enrolled (actual)
623
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Change in Glycemic Control (Patient Participants) During Intervention Period — 8.64; 8.53; 8.00; 8.31 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FAMS 2.0 (Behavioral); Print Materials (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycemic Control (Patient Participants) During Intervention Period |
8.64; 8.53; 8.00; 8.31; 8.23; 8.05 | — |
| PRIMARY Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects |
8.64; 8.53; 7.99; 8.04; 8.21; 8.04 | — |
| PRIMARY Change in Diabetes Distress (Patient Participants) During Intervention Period |
38.8; 38.1; 30.1; 32.9; 26.5; 30.6 | — |
| PRIMARY Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect |
38.8; 38.1; 26.2; 27.8 | — |
| PRIMARY Change in Psychosocial Well-being (Patient Participants) During Intervention Period |
55.6; 56.5; 62.5; 57.5; 62.2; 61.4 | — |
| PRIMARY Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect |
55.6; 56.5; 62.0; 65.3 | — |
| SECONDARY Change in Diabetes Distress (Support Person Participants) During Intervention Period |
34.2; 31.4; 31.9; 28.4; 30.2; 28.3 | — |
| SECONDARY Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect |
34.2; 31.4; 28.9; 27.8 | — |
| SECONDARY Change in Support Burden (Support Person Participants) During Intervention Period |
0.392; 0.360; 0.341; 0.368; 0.392; 0.366 | — |
| SECONDARY Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect |
0.392; 0.360; 0.301; 0.368 | — |
Summary
This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.
Eligibility Criteria
Inclusion Criteria
PATIENTS:
- Speaks and reads in English
- 18-75 years old
- Diagnosed with type 2 diabetes
- Receiving outpatient care from a partnering clinic
- Community dwelling (e.g., not in a nursing facility)
- Prescribed at least one daily diabetes medication
- Owns a mobile phone
SUPPORT PERSONS:
- Speaks and reads in English
- 18 years or older
- Owns a mobile phone
Exclusion Criteria
PATIENTS:
- Unable to communicate by phone
- Pregnant currently
- Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
- Diagnosed with end-stage renal disease
- Receiving hospice services
- Diagnosed with congestive heart failure
- Diagnosed with dementia
- Diagnosed with schizophrenia
- Reported current abuse during screening
- Demonstrates inability to receive and respond to a text
- Does not take medication on his/her own/medication administered by someone else
SUPPORT PERSONS:
- Demonstrates inability to receive and respond to a text
Data sourced from ClinicalTrials.gov (NCT04347291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.